Real-World Glycemic Outcomes of > 3,300 Children and Adolescents with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management

The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system that allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments. The System enables automatic upload of data for all users initiating the system, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with type 1 diabetes (T1D) aged <18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 3,369 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged <6y (n=182), 6 to 12y (n=2,050), and 13 to 17y (n=1,137) were available at the time of analysis. Users were aged mean±SD 10.9±3.4y with median 146 days of system use. Outcomes are shown in the Table for each age group. Median time in target range (70-180mg/dL) was 74.0%, 70.7%, and 67.1% for each age group, respectively. Time <70mg/dL in each age group was low: median 2.7%, 1.8%, and 1.2%, respectively. These results are the first to demonstrate that in over 3,000 children and adolescents using the Omnipod 5 System in a real-world setting, highly favorable glycemic outcomes are achievable and are similar to those first reported in pivotal trials. Disclosure J.Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Cecelia Health, StartUp Health T1D Moonshot, Consultant; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Lilly, Research Support; Insulet Corporation, Medtronic, NIH - National Institutes of Health, Juvenile Diabetes Research Foundation (JDRF), Speaker's Bureau; Insulet Corporation, Zealand Pharma A/S, Lilly, Medtronic. D.Desalvo: Consultant; Dexcom, Inc., Research Support; Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation. Funding Insulet Corporation